Uncontrolled evidence in rare cancers Paolo G. Casali - - PowerPoint PPT Presentation

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Uncontrolled evidence in rare cancers Paolo G. Casali - - PowerPoint PPT Presentation

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Uncontrolled evidence in rare cancers Paolo G. Casali paolo.casali@istitutotumori.mi.it R Eur Eur J C J Can ance cer 201 r 2011;47 1;47:249 :2493 Clinical decision-making Methods to combine evidence New study designs

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Uncontrolled evidence in rare cancers

Paolo G. Casali

paolo.casali@istitutotumori.mi.it

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R

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Eur Eur J C J Can ance cer 201 r 2011;47 1;47:249 :2493

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  • Clinical decision-making
  • Methods to combine evidence
  • New study designs
  • Surrogate end points
  • Organization of studies
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Prospective clinical data bases

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«Big clinical data»…

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Phase III Phase I

dose! activity!

Phase II

efficacy!

standard  MTD  OR  OS  QoL

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Boolell V et al. Cancers 2015;71815

Lung cancer

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…….

Soft tissue sarcomas & GIST

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R

ADM 75 mg/sqm + IFX 7.5 g/sqm ADM 75 mg/sqm

EORTC Soft Tissue & Bone Sarcoma Group

STS: advanced disease

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La Lanc ncet et On Onco col l 20 2014 14;15:41 ;15:415

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J Clin Oncol 2015;Epub

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Mol Cancer Therap 2009;8:449

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Van an Der er Gra Graaf af WTA WTA et et al, al, La Lanc ncet et 20 2012 12;379 ;379:187 :1879

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Van an Der er Gra Graaf af WTA WTA et et al, al, La Lanc ncet et 20 2012 12;379 ;379:187 :1879

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Italiano A et al. Patterns of care and outcome of patients (pts) with metastatic soft-tissue sarcoma (STS) according to histological subtype and treatment setting: The METASTAR study. ASCO Ann. Meet. 2016, #11014

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Leiomyosarcoma

ADM GEM TRB DTIC PAZO

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t

T

response progression

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Tumor response as a surrogate

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  • %?

Quality of life

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Quality of life

  • %?
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Survival…

  • %?
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BMJ 2003;327:1459

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N N Eng Engl l J M J Med ed 198 1987;31 7;316:25 6:250

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GIST: tumor response

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GIST: tumor response

15% 10%

Choi’s

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Choi’s RECIST

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5 HU 57 HU 39 HU 13 HU 61 HU 15 HU 83 HU 36 HU 57 HU 9 HU 52 HU 3 HU

  • 2 HU
  • 18 HU -34 HU

9 HU 5 HU

  • 9 HU
  • 13 HU

3 HU 20 HU 10 HU

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Postow MA et al. J Clin Oncol 2015;33:1974

Immune therapies: tumor response

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Karnofsky DA, 1961;6:709

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Reliability (reproducibility)

= !

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J Na J Natl tl Can ance cer r In Inst 2 st 200 000;92 0;92:205 :205

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J Na J Natl tl Can ance cer r In Inst 2 st 200 000;92 0;92:205 :205

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  • 1. Personalized tool
  • %?
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  • 2. Volume
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  • 3. Non-dimensional changes
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  • 4. Temporal dimension

t

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  • 5. Continuous variable
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t

  • 6. Growth rate
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t

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Boo

  • oth

th CM et et al.

  • al. Eur J C

Eur J Can ance cer r 20 2008 08;44:25 ;44:25

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Con

  • ntr

troll

  • ll Cli

lin n Trials rials 20 2000 00;21:34 ;21:343

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Reliability (reproducibility)

= !

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paolo.casali@istitutotumori.mi.it @casali_pg